Heart failure & cardiomyopathiesRandomised controlled trial
Long-Term Efficacy and Safety of Acoramidis in ATTR-CM: Initial Report From the Open-Label Extension of the ATTRibute-CM Trial
- Open-label extension of the ATTRibute-CM randomised controlled trial
- ongoing
Authors' conclusion
Early initiation and continuous use of acoramidis in the ATTRibute-CM study through month 42 of the ongoing OLE study were associated with sustained clinical benefits in a contemporary transthyretin amyloid cardiomyopathy cohort, with no clinically important safety issues newly identified.
Study context
- Population
- Participants with transthyretin amyloid cardiomyopathy who completed ATTRibute-CM and enrolled in the OLE (concomitant tafamidis discontinued)438 of 632 completed ATTRibute-CM
- Participants
- 389 participants
- Comparison
- Continuous acoramidis vs placebo switched to acoramidis
- Continuous acoramidisn = 263
- Placebo to acoramidisn = 126reference
Primary result
As reported in the abstract
All-cause mortality or first CV-related hospitalization · month 42
Hazard ratio
0.57
95% CI 0.46–0.72
P < 0.0001
Continuous acoramidis vs Placebo to acoramidis
HR 0.57 (95% CI 0.46–0.72); P < 0.0001
Further findings
| Outcome | HR (95% CI) | |
|---|---|---|
| All-cause mortality · month 42 | 0.64 (0.47–0.88) | |
| First CV-related hospitalization · month 42 | 0.53 (0.41–0.69) | |
| 0.512Hazard ratio (log scale) |
NT-proBNP and 6-minute walk distance
- Treatment effects favoured continuous acoramidis
Serum transthyretin
- Prompt increase on initiation of open-label acoramidis in placebo-to-acoramidis
KCCQ Overall Summary score
- Quality of life well preserved with continuous acoramidis vs placebo to acoramidis
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Long-Term Efficacy and Safety of Acoramidis in ATTR-CM: Initial Report From the Open-Label Extension of the ATTRibute-CM Trial. Circulation. Published 18 November 2024. doi:10.1161/circulationaha.124.072771
Summarised from the published abstract; every number is checked against it